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Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

Trial Status: Active

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.

Inclusion Criteria

  • Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
  • Patients for whom surgical or radiological treatment of lesions is contraindicated
  • At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Anticipated life expectancy >12 weeks
  • All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.

Exclusion Criteria

  • Prior treatment with an oncolytic therapy
  • Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
  • Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  • Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
  • Untreated brain metastasis(es) that may be considered active.
  • Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  • History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Wanxing Chai-Ho
Phone: 310-825-6301
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: IN_REVIEW

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: APPROVED

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW
Columbus
Ohio State University Comprehensive Cancer Center
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Replimune Inc.

  • Primary ID RPL-002-18
  • Secondary IDs NCI-2019-06779
  • Clinicaltrials.gov ID NCT04050436